CDRH publishes a list of final and draft guidances to be published in FY 2024.
A RAPS publication says FDA is likely to publish a draft guidance on plans for clinical trial diversity by the end of this year.
FDA clears a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system.
FDA posts a final guidance entitled Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
FDA approves Medtronics next-generation SynchroMed III intrathecal drug delivery system for patients with chronic pain, cancer pain, and severe spasti...
Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage I...
Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selpercatinib).
